Circular No. 06/2023/TT-BYT amends and supplements certain provisions of Circular No. 15/2019/TT-BYT dated July 11, 2019, issued by the Minister of Health, concerning the tendering of medicines at public health facilities.

CIRCULAR

AMENDMENTS AND SUPPLEMENTS TO CERTAIN ARTICLES OF CIRCULAR NO. 15/2019/TT-BYT DATED JULY 11, 2019 OF THE MINISTER OF HEALTH ON PROCUREMENT OF MEDICINES AT PUBLIC HEALTH INSTITUTIONS

Pursuant to the Law on Procurement dated November 26, 2013;

Pursuant to the Medicine Law dated April 6, 2016;

Pursuant to Decree No. 63/2014/NĐ-CP dated June 26, 2014 of the Government detailing certain provisions of the Law on Procurement regarding the selection of contractors;

Pursuant to the Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government detailing some provisions and measures for implementing the Medicine Law;

Pursuant to Decree No. 95/2022/NĐ-CP dated November 15, 2022 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to Circular No. 9134/BKHĐT-QLĐT dated December 15, 2022 of the Ministry of Planning and Investment on online procurement for herbal medicine and traditional medicine packages;

At the proposal of the Director of the Department of Planning and Finance; the Director of the Drug Administration; the Director of the Traditional Medicine Management Department;

The Minister of Health issues this Circular amending and supplementing certain articles of Circular No. 15/2019/TT-BYT dated July 11, 2019 of the Minister of Health on procurement of medicines at public health institutions.

Article 1. Amending and supplementing certain articles of Circular No. 15/2019/TT-BYT dated July 11, 2019 of the Minister of Health on procurement of medicines at public health institutions (hereinafter referred to as Circular No. 15/2019/TT-BYT).

1. Amendment Clause 1 of Article 1 as follows:

"1. This Circular stipulates the procurement of medicines including: chemical drugs (including radioactive drugs and labeled substances), vaccines, biological products, herbal medicines, traditional medicines, herbal medicines and traditional medicinal ingredients at public health institutions, specifically: the division of tender packages, groups of medicines; planning, form, method, organization of selecting contractors to supply medicines; regulations on centralized purchasing and price negotiation of medicines using state funds, health insurance funds, income from medical services, and other lawful sources of income of public health institutions."

2. Amendment and supplementation Article 3 as follows:

a) Amend Clause 1 of Article 3 as follows:

“1. Strict Regulatory Authority (SRA) and European Medicines Agency (EMA) are the regulatory authorities specified in Clause 9 of Article 2 of Circular No. 08/2022/TT-BYT dated September 5, 2022 of the Minister of Health on registration and circulation of medicines and raw materials for medicines."

b) Supplement Clause 1a following Clause 1 of Article 3 as follows:

“1a. Country listed in SRA or EMA is a country with a Strict Regulatory Authority (SRA) or European Medicines Agency (EMA)."

c) Amend Clause 6 of Article 3 as follows:

“6. Good Agricultural and Collection Practices (GACP) are practices for cultivation, harvesting, initial processing, manufacturing, transportation, and storage aimed at ensuring the quality, safety, and efficacy of herbal medicines and products derived from herbal medicines."

3. Amendment Article 4 as follows:

"Article 4. Responsibilities for planning and organizing the selection of contractors to supply medicines

1. Responsibilities for planning the selection of contractors

a) For medicines included in the National Centralized Procurement Medicine List and medicines subject to price negotiation:

- Medicines listed in Section A of the National Centralized Procurement Medicine List issued by the Minister of Health that meet the technical criteria specified in Clauses 1 and 2 of Article 7 of this Circular and medicines listed in the Price Negotiation Medicine List issued by the Minister of Health (excluding antiretroviral drugs for HIV/AIDS treatment): The National Centralized Medicine Procurement Center is responsible for planning the selection of contractors to supply medicines. The plan is based on the medicine usage needs of healthcare facilities as notified by the National Centralized Medicine Procurement Center;

- Antiretroviral drugs for HIV/AIDS treatment listed in Section B of the National Centralized Procurement Medicine List and in the Price Negotiation Medicine List issued by the Minister of Health: The National Centralized Medicine Procurement Center is responsible for planning the selection of contractors to supply medicines. The plan is based on the medicine usage needs of healthcare facilities as notified by the AIDS Control Center;

- Medicines listed in Section C of the National Centralized Procurement Medicine List issued by the Minister of Health: The entity assigned the task of national centralized procurement of medicines is responsible for planning the selection of contractors to supply medicines;

- The maximum duration of framework agreements and contracts is 36 months, divided according to each group of medicines and supply progress quarterly and annually.

b) For medicines included in the Provincial Centralized Procurement Medicine List:

- The provincial centralized medicine procurement unit is responsible for building plans for the selection of contractors to supply medicines. The plan is based on the medicine usage needs of healthcare facilities as notified by the provincial centralized medicine procurement unit;

- The maximum duration of framework agreements and contracts is 36 months, divided according to each group of medicines and supply progress quarterly and annually.

c) For medicines not covered by the National Centralized Medicine Procurement Center, the entity assigned the task of national centralized procurement of medicines, and the provincial centralized medicine procurement unit as specified in points a and b of this clause, healthcare facilities are responsible for planning the selection of contractors to supply medicines; the maximum contract duration is 12 months, divided according to each group of medicines.

2. Responsibilities for organizing the selection of contractors

a) For medicines included in the National Centralized Procurement Medicine List and medicines subject to price negotiation:

- Medicines listed in Section A of the National Centralized Procurement Medicine List issued by the Minister of Health that meet the technical criteria specified in Clauses 1 and 2 of Article 7 of this Circular, medicines listed in Section B of the National Centralized Procurement Medicine List, and medicines listed in the Price Negotiation Medicine List issued by the Minister of Health: The National Centralized Medicine Procurement Center is responsible for organizing the selection of contractors to supply medicines in accordance with Chapters IV and V of this Circular;

- Medicines listed in Section C of the National Centralized Procurement Medicine List issued by the Minister of Health: The entity assigned the task of national centralized procurement of medicines is responsible for organizing the selection of contractors to supply medicines in accordance with Chapter IV of this Circular.

b) For medicines included in the Provincial Centralized Procurement Medicine List:

The provincial centralized medicine procurement unit is responsible for organizing the selection of contractors to supply medicines in accordance with Chapter IV of this Circular.

c) For medicines not procured by the National Centralized Medicine Procurement Center, the Units assigned the task of national centralized medicine procurement and local centralized medicine procurement units shall organize the selection of contractors as stipulated in points a and b of this clause. Medical facilities are responsible for organizing the selection of contractors to supply medicines in accordance with the provisions of Chapter III of this Circular.

3. In cases where medical facilities have a need to procure medicines listed in Section C of the National Centralized Bidding Medicine List issued by the Minister of Health for the purpose of providing medical examination and treatment services, such procurement may be carried out in accordance with the provisions of Chapter III of this Circular.”

4. Amend Article 7 as follows:

“Article 7. Generic Medicine Tender Package

A generic medicine tender package may include one or more generic medicines, each generic medicine category must be divided into groups, each generic medicine within a group is part of the tender package. The generic medicine tender package is divided into five (5) groups based on technical criteria, specifically as follows:

1. Group 1 includes medicines that meet one of the following three (3) criteria:

a) Produced entirely on a drug production line meeting EU-GMP principles or equivalent standards at a facility listed in the SRA or EMA list and announced by the Vietnamese Drug Administration as meeting EU-GMP principles or equivalent standards;

b) Included in the list of original brand-name drugs or reference biological products published by the Ministry of Health, except for original brand-name drugs or reference biological products included in the list of medicines subject to price negotiation by the Minister of Health and for which the results of price negotiations have been announced;

c) Produced entirely in Vietnam and must meet the following criteria simultaneously:

- Produced entirely on a drug production line meeting EU-GMP principles or equivalent standards and announced by the Vietnamese Drug Administration as meeting EU-GMP principles or equivalent standards;

- Approved for circulation by the drug regulatory authority of a country listed in the SRA or EMA list in accordance with Clause 8, Article 50 of this Circular;

- The medicine circulating in Vietnam and the medicine approved for circulation by the drug regulatory authority of a country listed in the SRA or EMA list must have the same formulation, production process, quality standards, testing methods; active ingredients and excipients must have the same quality standards, manufacturing sites according to Clause 8, Article 50 of this Circular.

2. Group 2 includes medicines that meet one of the following two (2) criteria:

a) Produced entirely on a drug production line meeting EU-GMP principles or equivalent standards and announced by the Vietnamese Drug Administration as meeting EU-GMP principles or equivalent standards;

b) Produced entirely on a drug production line in a country that is a member of both PIC/s and ICH, certified by the competent authority of that country as meeting PIC/s-GMP principles, and announced by the Vietnamese Drug Administration as meeting PIC/s-GMP principles.

3. Group 3 includes medicines that have been granted registration certificates for circulation or import permits for circulation in Vietnam and announced by the Vietnamese Drug Administration as having bioequivalence evidence.

4. Group 4 includes medicines produced entirely on a production line in Vietnam and announced by the Vietnamese Drug Administration as meeting GMP principles.

5. Group 5 includes medicines that have been granted registration certificates for circulation or import permits for circulation in Vietnam.”

5. Amend Clause 2 of Article 8 as follows:

“2. The original brand-name drug or therapeutic equivalent medicine tender package may include one or more original brand-name drugs or therapeutic equivalents of original brand-name drugs or reference biological products, each medicine being a part of the tender package. Medicines in the original brand-name drug or therapeutic equivalent medicine tender package must meet the following two (2) criteria simultaneously:

a) Included in the list of original brand-name drugs, therapeutic equivalents of original brand-name drugs, and reference biological products published by the Ministry of Health, except for original brand-name drugs included in the list of medicines subject to price negotiation by the Minister of Health and for which the results of price negotiations have been announced;

b) Produced entirely in countries listed in the SRA or EMA list; or produced one or several stages in Vietnam and the remaining stages produced in countries listed in the SRA or EMA list; or produced entirely in Vietnam; or approved for circulation by the drug regulatory authorities of countries listed in the SRA or EMA list.”

6. Amend Article 9 is as follows:

"Article 9. Package of herbal medicines, traditional medicine products containing herbal ingredients combined with chemical drug substances, traditional medicine (excluding traditional herbal medicines)

The package of herbal medicines, traditional medicine products containing herbal ingredients combined with chemical drug substances, traditional medicine (excluding traditional herbal medicines) may include one or more medicines, each category of medicine must be divided into groups, each medicine within a group is part of the package. The package of herbal medicines, traditional medicine products containing herbal ingredients combined with chemical drug substances, traditional medicine is divided into 04 (four) groups according to technical criteria as follows:

1. Group 1 includes medicines produced entirely on pharmaceutical production lines in Vietnam announced by the Vietnamese drug management agency to meet GMP principles and standards, and in the formula of the medicine, all herbal ingredients are announced by the Vietnamese drug management agency to meet GACP principles and standards.

2. Group 2 includes medicines produced entirely on pharmaceutical production lines in Vietnam announced by the Vietnamese drug management agency to meet GMP principles and standards, and in the formula of the medicine, at least 50% of the quantity of herbal ingredients are announced by the Vietnamese drug management agency to meet GACP principles and standards.

3. Group 3 includes medicines produced entirely on production lines in Vietnam announced by the Vietnamese drug management agency to meet GMP principles and standards.

4. Group 4 includes herbal medicines, traditional medicine products containing herbal ingredients combined with chemical drug substances, traditional medicine that have been granted circulation permits in Vietnam."

7. Amend Article 10 is as follows:

"Article 10. Package of traditional herbal medicines (excluding standardized traditional herbal medicines in the form of decoctions, powders, extracts, essential oils, resins, gums, jellies)

The package of traditional herbal medicines may include one or more traditional herbal medicines, each category of traditional herbal medicine must be divided into groups, each traditional herbal medicine within a group is part of the package. The package of traditional herbal medicines is divided into 03 (three) groups according to technical criteria as follows:

1. Group 1 includes traditional herbal medicines produced entirely on pharmaceutical production lines in Vietnam announced by the Vietnamese drug management agency to meet GMP principles and standards for traditional herbal medicines and produced from herbal ingredients announced by the Vietnamese drug management agency to meet GACP principles and standards.

2. Group 2 includes traditional herbal medicines produced entirely on pharmaceutical production lines in Vietnam announced by the Vietnamese drug management agency to meet GMP principles and standards for traditional herbal medicines.

3. Group 3 includes traditional herbal medicines not meeting the criteria specified in Clause 1 and Clause 2 of this Article but have been granted circulation permits in Vietnam."

8. Add Article 10a after Article 10 as follows:

"Article 10a. Package of standardized traditional herbal medicines in the form of decoctions, powders, extracts, essential oils, resins, gums, jellies

The package of standardized traditional herbal medicines in the form of decoctions, powders, extracts, essential oils, resins, gums, jellies may include one or more traditional herbal medicines, each category of traditional herbal medicine must be divided into groups, each traditional herbal medicine within a group is part of the package. The package of standardized traditional herbal medicines in the form of decoctions, powders, extracts, essential oils, resins, gums, jellies is divided into 03 (three) groups according to technical criteria as follows:

1. Group 1 includes traditional herbal medicines produced entirely on pharmaceutical production lines in Vietnam announced by the Vietnamese drug management agency to meet GMP principles and standards and produced from herbal ingredients announced by the Vietnamese drug management agency to meet GACP principles and standards.

2. Group 2 includes traditional herbal medicines produced entirely on pharmaceutical production lines in Vietnam announced by the Vietnamese drug management agency to meet GMP principles and standards.

3. Group 3 includes traditional herbal medicines not meeting the criteria specified in Clause 1 and Clause 2 of this Article but have been granted circulation permits in Vietnam".

9. Amend Article 11 is as follows:

"Article 11. Herb package (excluding semi-finished herbal products in the form of extract, powder, decoction, essential oil, resin, gum, jelly that have been standardized)

The herb package may contain one or more herbs, each category of herb must be divided into groups, each herb within a group is part of the package. The herb package is divided into 03 (three) groups according to technical criteria as follows:

1. Group 1 includes herbs announced by the Vietnamese drug management agency as meeting the principles and GAP standards.

2. Group 2 includes herbs that are fully preprocessed on production lines announced by the Vietnamese drug management agency as meeting the principles and GMP standards for raw materials from herbs.

3. Group 3 includes herbs that do not meet the criteria specified in Clause 1 and Clause 2 of this Article."

10. Supplement Article 11a following Article 11 as follows:

"Article 11a. Semi-finished herbal product package in the form of extract, powder, decoction, essential oil, resin, gum, jelly that have been standardized

The semi-finished herbal product package in the form of extract, powder, decoction, essential oil, resin, gum, jelly that have been standardized may contain one or more semi-finished herbal products, each category of semi-finished herbal product must be divided into groups, each semi-finished herbal product within a group is part of the package. The semi-finished herbal product package in the form of extract, powder, decoction, essential oil, resin, gum, jelly is divided into 03 (three) groups according to technical criteria as follows:

1. Group 1 includes semi-finished herbal products produced entirely on production lines in Vietnam announced by the Vietnamese drug management agency as meeting the principles and GMP standards for raw materials from herbs and produced from herbs announced by the Vietnamese drug management agency as meeting the principles and GAP standards.

2. Group 2 includes semi-finished herbal products produced entirely on production lines in Vietnam announced by the Vietnamese drug management agency as meeting the principles and GMP standards for raw materials from herbs.

3. Group 3 includes semi-finished herbal products that do not meet the criteria specified in Clause 1 and Clause 2 of this Article but have been granted a permit for circulation in Vietnam."

11. Amend and supplement Article 12 as follows:

a) Amend and supplement Clause 3 of Article 12 as follows:

"3. Drug package of herbs, drugs with herbal components combined with chemical pharmaceutical substances, traditional medicine (excluding traditional medicine ingredients):

a) Drugs meeting the criteria of Group 1 can be tendered for Groups 1, 2, 3, and 4;

b) Drugs meeting the criteria of Group 2 can be tendered for Groups 2, 3, and 4;

c) Drugs meeting the criteria of Group 3 can be tendered for Groups 3 and 4;

d) Drugs not meeting the criteria of Groups 1, 2, and 3 can only be tendered for Group 4."

b) Amend and supplement Clause 4 of Article 12 as follows:

"4. Traditional medicine ingredient package (excluding traditional medicine ingredients in the form of extract, powder, decoction, essential oil, resin, gum, jelly that have been standardized):

a) Traditional medicine ingredients meeting the criteria of Group 1 can be tendered for Groups 1, 2, and 3;

b) Traditional medicine ingredients meeting the criteria of Group 2 can be tendered for Groups 2 and 3;

c) Traditional medicine ingredients not meeting the criteria of Groups 1 and 2 can only be tendered for Group 3."

c) Supplement Clause 4a following Clause 4 of Article 12 as follows:

"4a. Traditional medicine ingredient package in the form of extract, powder, decoction, essential oil, resin, gum, jelly that have been standardized:

a) Traditional medicine ingredients meeting the criteria of Group 1 can be tendered for Groups 1, 2, and 3;

b) Traditional medicine ingredients meeting the criteria of Group 2 can be tendered for Groups 2 and 3;

c) Traditional medicine ingredients not meeting the criteria of Groups 1 and 2 can only be tendered for Group 3."

d) Amend and supplement Clause 5 of Article 12 as follows:

"5. Herb package (excluding semi-finished herbal products in the form of extract, powder, decoction, essential oil, resin, gum, jelly that have been standardized):

a) Herbs meeting the criteria of Group 1 can be tendered for Groups 1, 2, and 3;

b) Herbs meeting the criteria of Group 2 can be tendered for Groups 2 and 3;

c) Herbs not meeting the criteria of Groups 1 and 2 can only be tendered for Group 3."

d) Supplement Clause 5a following Clause 5 of Article 12 as follows:

"5a. Semi-finished herbal product package in the form of extract, powder, decoction, essential oil, resin, gum, jelly that have been standardized:

a) Semi-finished herbal products meeting the criteria of Group 1 can be tendered for Groups 1, 2, and 3;

b) Semi-finished herbal products meeting the criteria of Group 2 can be tendered for Groups 2 and 3;

c) Semi-finished herbal products not meeting the criteria of Groups 1 and 2 can only be tendered for Group 3."

12. Amend Point b Clause 1 of Article 13 as follows:

"b) Health insurance fund sources, income from medical examination and treatment services:

Based on the actual purchase and use of drugs from the health insurance fund and income from medical examination and treatment services of the previous consecutive year and the forecasted need for drug use in the planning year of healthcare facilities."

13. Amendment Article 14 is as follows:

a) Amend Clause 2 of Article 14 as follows:

“2. The recording of the drug formulation type for the tender package of generic drugs, herbal medicine tender packages, drugs with combined herbal and chemical components, and traditional medicines shall be carried out according to the provisions set forth in Appendix 4 attached to this Circular. Formulations (marked ⁽*⁾) shall be recorded separately in the tender selection plan based on the following principles:

a) They may only be recorded separately if they have the same formulation as the original brand-name drug or reference biological product with the same active ingredient, route of administration, or drugs with the same active ingredient and route of administration that have been approved for circulation in SRA or EMA countries;

b) In cases where the drug does not fall under Point a of Clause 2 of this Article, healthcare facilities must clearly explain the necessity of using such formulations regarding their essentiality, the expected quantity, and their use only when absolutely necessary due to the inability to use other formulations or when other formulations do not meet treatment requirements.”

b) Amend Point c of Clause 4 of Article 14 as follows:

“c) When preparing the tender selection plan, units may refer to one of the following information sources or documents to serve as the basis for establishing the unit price of each drug, herbal medicine, or traditional medicine:

- The winning bid prices of drugs, herbal medicines, or traditional medicines according to technical criteria groups from healthcare facilities or centralized provincial-level or national-level bids within the last 12 months, or negotiated prices still in effect from framework agreements published on the Ministry of Health's Electronic Information Portal (Drug Administration Department, Traditional Medicine Management Department). If not published on the Ministry of Health's Electronic Information Portal (Drug Administration Department, Traditional Medicine Management Department), then rely on the decision on the winning bid or the announcement of the winning bid or publicly available information pursuant to Clause 6 of Article 20 of Decree No. 63/2014/ND-CP dated June 26, 2014, of the Government detailing certain provisions of the Law on Bidding concerning the selection of contractors (hereinafter referred to as Decree No. 63/2014/ND-CP).

- Quotation or sales invoice, specifically as follows:

+ For chemical drugs, biologics, vaccines, herbal medicines, and traditional medicines: refer to three quotations or sales invoices from different suppliers at the time of preparing the tender selection plan. In cases where there are fewer than three quotations or sales invoices from different suppliers, the head of the unit bases the quotation or sales invoice from at least one supplier at the time of preparing the tender selection plan, provides an explanation, takes responsibility for the proposed planned price, and ensures it does not exceed the effective wholesale price of the referenced drug;

+ For herbal medicines and traditional medicines: refer to three quotations or sales invoices from different suppliers at the time of preparing the tender selection plan. In cases where there are fewer than three quotations or sales invoices from different suppliers, the head of the unit bases the quotation or sales invoice from at least one supplier at the time of preparing the tender selection plan, provides an explanation, and takes responsibility for the proposed planned price being consistent with the market price of those herbal medicines and traditional medicines at the time of preparing the tender selection plan.”

14. Amend Clause 1 of Article 15 as follows:

“1. Responsibility for reviewing the tender selection plan:

The head of the healthcare facility is responsible for preparing the tender selection plan for drug supply to be reviewed and approved by the competent authority or the agency/unit authorized to approve in order to ensure the provision of drugs for medical examination and treatment activities at the healthcare facility.”

15. Amend and supplement Clause 1 of Article 16 as follows:

“1. Organizing the review:

a) For agencies at the level of ministries, central government agencies, and other central agencies: follow the provisions of Clause 4 of Article 104 of Decree No. 63/2014/ND-CP;

b) For agencies and units under the management of the Ministry of Health: the organization assigned tasks by the agency/unit authorized to decide on procurement is responsible for reviewing the tender selection plan;

c) For public healthcare facilities under the management of localities: follow the provisions of Clause 3 of Article 104 of Decree No. 63/2014/ND-CP;

d) For healthcare facilities not falling under Point a, Point b, and Point c of Clause 1 of this Article, the specialized unit directly under the healthcare facility organizes the review of the tender selection plan.”

16. Amend Clause 1 of Article 17 as follows:

“1. Approval authority for the tender selection plan shall be implemented according to the provisions of Clause 1 of Article 76 of Decree No. 63/2014/ND-CP.”

17. Amend and supplement Article 18 is as follows:

"Article 18. Provisions on organizing the selection of contractors for medicines listed in the Centralized Tendering Medicine List and the Medicine List subject to price negotiation form of healthcare facilities

1. Healthcare facilities may organize the selection of contractors according to the provisions from Article 13 to Article 17 of this Circular for medicines listed in the Centralized Tendering Medicine List and the Medicine List subject to price negotiation form when they meet one of the following circumstances:

a) Healthcare facilities have a need to use medicines listed in the Centralized Tendering Medicine List and the Medicine List subject to price negotiation form if at the time of approving the contractor selection plan, there is no result of centralized tendering, price negotiation results announced or there are results of centralized tendering, price negotiation results announced but the validity period of the framework agreement signed still has at least three months remaining, requiring the organization of contractor selection to use the medicines when the validity period of the framework agreement expires;

b) Medicines listed in the Centralized Tendering Medicine List and the Medicine List subject to price negotiation form have been contracted but the winning contractor cannot supply the medicines;

c) Healthcare facilities have used up the quantity of medicines allocated in the framework agreement and exceeded the adjustment capacity specified in Clause 5, Article 37, Clause 13, Article 40, and Clause 12, Article 41 of this Circular;

d) Healthcare facilities established after the completion of the drug procurement demand consolidation and exceeding the adjustment capacity of the Centralized Drug Procurement Unit.

2. To enable healthcare facilities to proactively organize the selection of contractors to ensure the supply of medicines for medical examination and treatment work, before March 15 each year, when procurement progress is not timely and before the expiration of the signed framework agreement with at least three months remaining, the Centralized Drug Procurement Unit shall promptly notify the organization of contractor selection for cases stipulated in Clause 1 of this Article."

18. Supplement Appendix 14 in Appendix 01 and Appendix 15 in Appendix 02 issued together with this Circular as follows:

a) Appendix 14: Sample tender document for online tendering for the procurement package of medicinal materials and traditional herbal medicine (excluding standardized medicinal materials and traditional herbal medicine in the form of extract, powder, decoction, essential oil, resin, gum, jelly) applying a one-stage one-envelope method.

b) Appendix 15: Sample tender document for online tendering for the procurement package of medicinal materials and traditional herbal medicine (excluding standardized medicinal materials and traditional herbal medicine in the form of extract, powder, decoction, essential oil, resin, gum, jelly) applying a one-stage two-envelope method.

19. Amend and supplement Clause 1 of Article 27 as follows:

"1. The preparation of tender documents and request for proposal for purchasing medicines must be carried out in accordance with the provisions of the Law on Bidding, detailed implementing regulations, and the following provisions:

a) For tender documents for the procurement package of original brand-name drugs or equivalent therapeutic drugs; generic drug procurement package; medicinal material procurement package, drugs containing medicinal material components combined with chemical drugs, traditional medicine (excluding traditional herbal medicine); traditional herbal medicine procurement package in the form of extract, powder, decoction, essential oil, resin, gum, jelly that have been standardized; semi-finished medicinal material procurement package in the form of extract, powder, decoction, essential oil, resin, gum, jelly that have been standardized:

- In case of online contractor selection, use Model No. 7A and Model No. 7B issued together with Circular No. 08/2022/TT-BKHDT dated May 31, 2022, of the Minister of Planning and Investment detailing the provision of information on bidding and contractor selection on the National Electronic Bidding System (hereinafter referred to as Circular No. 08/2022/TT-BKHDT) to prepare the E-Tender Document in accordance with Article 35 of Circular No. 08/2022/TT-BKHDT;

- In case of non-online contractor selection, use the tender document model prescribed in Appendix 7 and Appendix 8 issued together with this Circular.

b) For tender documents for the procurement package of medicinal materials (excluding semi-finished medicinal materials in the form of extract, powder, decoction, essential oil, resin, gum, jelly that have been standardized) and traditional herbal medicine procurement package (excluding traditional herbal medicine in the form of extract, powder, decoction, essential oil, resin, gum, jelly that have been standardized):

- In case of online contractor selection, use the tender document model prescribed in Appendix 01 and Appendix 02 issued together with this Circular,

- In case of non-online contractor selection, use the tender document model prescribed in Circular No. 09/2022/TT-BYT dated September 9, 2022, of the Minister of Health detailing the sample tender document for the procurement of medicinal materials and traditional herbal medicine at healthcare facilities.

c) For the request for proposal of the procurement package of medicines purchased through direct purchase, competitive quotation, and sole-source procurement: Units refer to the content and model of tender documents and requests for proposals issued by the Ministry of Health and the Ministry of Planning and Investment to build accordingly."

20. Amend and supplement Clause 3 of Article 30 as follows:

"3. Forms of bid security:

Contractors must implement bid security measures before the tender closing time (except in the case provided for in point c of this clause) in the following forms:

a) For packages applying online contractor selection, contractors must implement bid security measures in the form of a bank guarantee issued by a bank or credit institution operating legally in Vietnam.

b) For packages applying non-online contractor selection, contractors may choose one of the following bid security forms:

- Deposit;

- Escrow deposit;

- Bank guarantee issued by a bank or credit institution operating legally in Vietnam."

c) For tender packages with a bid guarantee value under VND 10 million, bidders do not need to submit a bid bond before the closing time of the tender. In this case, the bidder must commit that if invited for contract negotiations but fails to attend or refuses to negotiate the contract or violates the laws on public procurement leading to non-refund of the bid guarantee value, they will pay a specified amount as stipulated in the tender documents or request documents. The bidder will be named on the System and their account will be locked for six months from the date the Department of Public Procurement, Ministry of Planning and Investment receives the proposal letter from the tenderer.”

21. Amend and supplement Clause 2 of Article 31 as follows:

“2. The tenderer evaluates tender documents and proposal documents separately for each part of the tender package based on the provisions of the Public Procurement Law, detailed implementing regulations of the Public Procurement Law, and guidance documents of the Ministry of Planning and Investment and the Ministry of Health on selecting contractors; based on information about drugs (registration certificates for circulation, import permits), principles and standards of GMP of production facilities as approved in circulars or decisions of the Drug Administration, Traditional Medicine and Drugs Administration, or published on the Drug Administration’s and Traditional Medicine and Drugs Administration’s websites, and other relevant information. For the evaluation of contractor capacity and experience, it shall be conducted based on the total parts of the tender package in which the contractor participates.”

22. Amend and supplement Clause 1 and Clause 2 of Article 32 as follows:

“1. Contract negotiation shall be carried out in accordance with Article 19 of Decree No. 63/2014/ND-CP and shall be conducted before the tenderer proposes the successful bidder.

The bidder with the lowest bid price after corrections and adjustments, minus the lowest discount value (if applicable) for the lowest evaluated bid method; the lowest evaluated bid price for the evaluated bid price method; the highest combined technical and price score for the combined technical and price method, ranked first, shall be invited to negotiate the contract. If the invited bidder does not attend the negotiation or refuses to negotiate the contract, the bidder will not be refunded the bid guarantee value for the portion of the tender they did not negotiate.

2. Conditions for considering the proposal for awarding the contract shall be implemented in accordance with the provisions of Article 43 of the Public Procurement Law, issued tender documents, request documents, and the following provisions:

a) The tenderer shall propose the successful bidder for each part in the procurement plan for selecting contractors that has been approved (except for tender packages specified in point b of Clause 2 of this Article). Each part of the tender package may only propose one drug or traditional medicine ingredient that meets the technical and quality requirements stipulated in the tender documents and request documents, with the lowest bid price after corrections and adjustments, minus the lowest discount value (if applicable) for the lowest evaluated bid method; the lowest evaluated bid price for the evaluated bid price method; the highest combined technical and price score in the group of drugs for the combined technical and price method;

b) Specifically, for tender packages serving disaster prevention and rescue operations and epidemic control, which are purchased according to a quota and must be packaged according to the quota including multiple drug items: the tenderer may consider proposing the successful bidder according to the quota (including multiple parts, collectively referred to as the tender package) when each part of the tender package meets the technical and quality requirements stipulated in the tender documents and request documents, and the bid price of each part does not exceed the wholesale price declared and re-declared still in effect, and the total tender package price after corrections and adjustments, minus the lowest discount value (if applicable) for the lowest evaluated bid method; the lowest evaluated bid price for the evaluated bid price method. In this case, the tender package price must include the cost of packaging according to the quota.”

23. Amend Clause 5 of Article 35 as follows:

“5. Where one or more parts of the tender package have no bidders participating in the tender or no bidders meeting the requirements stated in the tender documents and request documents, or cannot be handled according to Clause 3 of Article 32 of this Circular, the tenderer shall separate these drugs into individual tender packages to submit for approval by the authorized person or unit with delegated authority to adjust the procurement plan for selecting contractors. The selection of contractors for parts with participating bidders who meet the technical requirements shall still be carried out in accordance with the regulations.”

24. Amend Clause 6 of Article 37 as follows:

“6. In cases where the tendered drug changes during the process of selecting contractors or supplying winning drugs, but the replacement drug was not quoted in the tender documents, the project owner may consider allowing the contractor to replace the drug to ensure timely supply of sufficient drugs for medical examination and treatment services, specifically:

a) Changes in one or several pieces of information related to the drug (including both original brand-name drugs and reference biological products) without changing the registration certificate for circulation or the import permit, including: drug name; name of the drug manufacturing facility; address of the drug manufacturing facility (production location unchanged); change in production location but the compliance with GMP principles and standards of the production facility remains unchanged; increase in drug shelf life; change in product packaging specifications. For original brand-name drugs and reference biological products with approved changes in production location, the replacement drug must be produced entirely in a country listed in the SRA or EMA list;

b) Changing the registration circulation number or obtaining a new import permit but other information remains unchanged (drug name, production facility, drug shelf life, compliance with principles, GMP standards of the production facility, quality standards; for substitute drugs, quality standards may change but must not be lower than the quality standards of the tendered drug or the updated version of the pharmacopoeia's quality standards). For original brand-name drugs and reference biological products, when changing the registration circulation number or obtaining a new import permit, the changed information must be announced by the Ministry of Health in the List of Original Brand-Name Drugs and Reference Biological Products.

c) Changing the way herbal medicine names are recorded without altering the essential components in the formula, and such changes have been approved by the competent state management agency.

When implementing drug substitution under the cases specified in points a, b, and c of this clause, the contractor must provide all necessary information for the tenderer to evaluate the substitution, including decisions, approval letters related to the content changes approved by the competent state management agency, and explanations and commitments regarding the unaltered quality standards of the tendered drug and the proposed substitute drug.

25. Amend Clause 5 of Article 38 as follows:

“5. Method of selecting contractors: Based on the scale of the tender package and the evaluation method of tender documents, proposal documents to propose the method of selecting contractors according to the provisions of Articles 28 and 29 of the Bidding Law.”

26. Add Clause 1a after Clause 1 of Article 41 as follows:

“1a. Documents attached to the centralized drug procurement registration document:

a) Summary report on the implementation results of the contractor selection process, drug usage situation of the previous year, quantity of drug inventory and unexecuted planned quantities at the time of budget preparation of healthcare facilities;

b) Summary explanation of the proposed drug purchase plan; if there is an increase or decrease of more than thirty percent (30%) compared to the previous year's usage quantity, a detailed explanation and description must be provided;

c) Minutes of the Drug and Treatment Council meeting or review minutes of healthcare facilities regarding the list, quantity, and usage needs of drugs for healthcare facilities managed by localities, ministries, and agencies within their jurisdiction.”

27. Amend and supplement Clause 5 of Article 42 as follows:

“5. Basis for negotiation and implementation of drug price negotiations:

a) For drugs subject to negotiation that are original brand-name drugs published by the Ministry of Health produced entirely in countries listed in the SRA or EMA lists with two (02) registration circulation certificates for Generic Group 1 drugs, the negotiation and implementation of drug price negotiations are based on the number of Generic Group 1 drug registration certificates; the winning bid price of Generic Group 1 drugs and the substitutability of the drug at the time of price negotiation.

b) For drugs subject to negotiation that are original brand-name drugs published by the Ministry of Health produced entirely in countries listed in the SRA or EMA lists with two (02) registration circulation certificates for Generic Group 1 drugs necessary for treatment needs; original brand-name drugs published by the Ministry of Health produced entirely in countries listed in the SRA or EMA lists with less than or equal to one (01) registration circulation certificate for Generic Group 1 drugs; drugs with one (01) to two (02) production facilities, in addition to the basis stipulated in point a of this clause, the negotiation and implementation of drug price negotiations also depend on the assessment of cost-effectiveness, safety, efficacy, cost-benefit, and cost-effectiveness.

c) For original brand-name drugs published by the Ministry of Health manufactured through processing and technology transfer in Vietnam, the negotiation and implementation of drug price negotiations follow the processing and technology transfer schedule.”

28. Amend Point g of Clause 4 of Article 45 as follows:

“g) The proposed winning bid price through price negotiation is the price agreed upon by the Negotiation Committee and the contractor. The National Centralized Procurement Center for Drugs will notify the contractor of the agreed price within seven working days from the date both parties agree on the negotiated price and proceed to negotiate a framework agreement with the contractor.”

29. Amend Point b of Clause 2 of Article 46 as follows:

“b) For drugs included in the list of drugs subject to price negotiation, if the negotiation fails (including original brand-name drugs processed and transferred in Vietnam), the National Centralized Procurement Center for Drugs will notify healthcare facilities about procurement solutions or alternative drug options based on the opinion of the Negotiation Committee.

For original brand-name drugs published by the Ministry of Health produced entirely in countries listed in the SRA or EMA lists with two (02) registration circulation certificates for Generic Group 1 drugs as stipulated in Article 7 of this Circular, if the price negotiation fails, healthcare facilities can organize the selection of contractors through open bidding for Generic Group 1 drugs according to the announcement of the National Centralized Procurement Center for Drugs.”

30. Amend and supplement Article 50 is as follows:

a) Amend Clause 2 of Article 50 as follows:

“2. The Minister of Health shall delegate the authority to decide on procurement of medicines for agencies and units directly using funds within the scope of management of the Ministry of Health to purchase medicines for the activities of such agencies and units and to fulfill tasks assigned by the Minister of Health.”

b) Amend Clause 4 of Article 50 as follows;

“4. The Drug Administration Department and the Traditional Medicine Administration Department shall be responsible for updating and publishing on their websites the following information:

a) Lists serving the selection of contractors, including:

- List of drug regulatory authorities of countries included in the SRA or EMA lists and list of countries included in the SRA or EMA lists;

- List of drug regulatory authorities of countries that are members of PIC/s and ICH;

- List of pharmaceutical manufacturing facilities in Vietnam evaluated by the Vietnamese drug regulatory authority as meeting WHO-GMP principles and standards;

- List of pharmaceutical manufacturing facilities meeting EU-GMP principles and standards or equivalent EU-GMP principles and standards; List of facilities meeting PIC/s-GMP principles and standards; List of facilities meeting WHO-GMP principles and standards;

- List of pharmaceutical manufacturing facilities in Vietnam evaluated by the Vietnamese Ministry of Health as meeting GMP principles and standards for herbal drugs or traditional medicine;

- List of pharmaceutical manufacturing facilities in Vietnam evaluated by the Vietnamese Ministry of Health as meeting GMP principles and standards for medicinal herbs and traditional medicine ingredients;

- List of pharmaceutical manufacturing facilities in Vietnam evaluated by the Vietnamese Ministry of Health as meeting GMP principles and standards for raw materials derived from medicinal herbs;

- List of drugs registered for circulation produced from cultivated, harvested, or naturally sourced medicinal herbs evaluated by the Vietnamese Ministry of Health as meeting GACP principles and standards.

b) Categories of medicines serving the selection of contractors, including:

- Category of medicines registered for circulation or granted import permits;

- Category of original brand-name medicines;

- Category of reference biological products;

- Category of medicines manufactured through technology transfer in Vietnam;

- Category of original brand-name medicines and reference biological products manufactured through technology transfer in Vietnam;

- Category of medicines with bioequivalence documentation;

- Category of medicines fully produced on production lines in Vietnam meeting Group 1 criteria specified in Point c Clause 1 of Article 7 of this Circular;

- Category of traditional medicine preparations in the form of extracts, powders, decoctions, essential oils, resins, gums, and jellies ensuring quality according to regulations set by the Ministry of Health for the management of traditional medicine and herbal drugs;

- Category of semi-finished herbal drug preparations in the form of extracts, powders, decoctions, essential oils, resins, gums, and jellies ensuring quality according to regulations set by the Ministry of Health for the management of raw material quality;

- Category of medicines listed in the National Product Catalogue;

- Category of medicines winning the "Vietnamese Medicine Star" award from the Ministry of Health;

- Category of medicinal herbs cultivated, harvested, or naturally sourced from facilities evaluated by the Vietnamese Ministry of Health as meeting GACP principles and standards;

- Category of medicines produced in Vietnam meeting treatment requirements, pricing, and supply capacity;

- Category of medicines produced from active pharmaceutical ingredients (APIs) produced in countries included in the SRA or EMA lists, APIs certified with CEP certificates;

- Category of medicines and manufacturing facilities, suppliers with violations related to quality or tendering and supply regulations;

c) Information on declared prices and re-declared prices of medicines;

d) Information on tendered prices of medicines, traditional medicines, and medicinal herbs at healthcare facilities;

đ) List of manufacturing facilities and suppliers of medicines meeting requirements for capacity, experience, and reputation to serve as a basis for limited tender invitations.”

c) Amend Clause 8 of Article 50 as follows:

“8. The entity requesting publication of the information specified in Point c Clause 1 of Article 7 of this Circular shall provide and bear legal responsibility for the accuracy of the following documents:

a) Legal documents issued by the drug regulatory authority of a country included in the SRA or EMA lists, bearing signatures, names of signatories, and seals of the competent national authority issuing the document, and must be legalized consularly according to regulations (original or certified copy).

In cases where the legal document is an electronic version, including cases without signatures, names of signatories, and seals of the competent national authority issuing the document, the entity shall submit the results of self-searching the legal document from the English-language website of the issuing authority, accompanied by a letter providing the online search link to the Ministry of Health (Drug Administration Department). The registering entity shall bear full legal responsibility for the legality and accuracy of these documents, information, and the results of the self-search conducted by the entity.

The legal document must include the following minimum content: name of the medicine, active ingredient, concentration or content of the active ingredient, dosage form, name and address of the manufacturing facility, confirmation that the medicine is approved for circulation in that country.

b) A declaration listing information to prove that medicines circulating in Vietnam and medicines approved for circulation by the drug regulatory authority of a country included in the SRA or EMA lists have the same formulation, production process, quality standards, testing methods; active ingredients and excipients must meet the same quality standards, manufacturing facilities, and production sites as stipulated in Appendix 13 attached to this Circular.”

d) Add Clause 10 to Article 50 as follows:

“10. Contractors participating in tenders for herbal medicines, medicines containing herbal components combined with chemical drugs, traditional medicines; tenders for medicinal herbs, semi-finished medicinal herb products, traditional medicine preparations produced from sources of medicinal herbs announced by the Vietnamese drug regulatory authority as meeting GACP principles and standards shall bear full legal responsibility for the following contents:

a) The accuracy of the files and documents proving that the medicines, medicinal herbs, and traditional medicine preparations participating in the tender are produced from sources of medicinal herbs announced by the Vietnamese drug regulatory authority as meeting GACP principles and standards.”

b) Medicines, traditional herbal medicines, and medicinal materials that have won bids shall be produced and supplied from sources of medicinal materials announced by the Vietnamese drug management agency to meet the principles and standards of GACP and in accordance with the technical standards set out in the tender invitation document.”

31. Amend and supplement Appendix 2 in Appendix 03 issued together with this Circular.

32. Amend and supplement Appendix 4 in Appendix 04 issued together with this Circular.

33. Amend Appendixes 7 and 8 as follows:

a) Amend Part 4 of Appendix Standard Evaluation Criteria for Technical Aspects of Medicines issued together with this Circular.

b) Amend Section 18.1 in Section 18 Ensuring Tender Participation in Chapter I, Part 1 as follows:

“18.1. When participating in the tender, the bidder must provide a bid security before the tender closing time in the form of a bank guarantee issued by a bank or credit institution legally operating in Vietnam or in the form of a deposit as stipulated in Section 18.2 CDNT. In case of using a bank guarantee, such guarantee must comply with Model No. 04(a) or Model No. 04(b) in Chapter IV - Bid Forms. If the bid security value is less than VND 10 million, it shall be implemented in accordance with Point c Clause 3 Article 30 of this Circular. In case the bid submission validity period is extended according to Section 17.2 CDNT, the validity period of the bid security shall also be correspondingly extended.”

In case of a consortium, the following two methods must be applied:

a) Each member of the consortium will separately provide bid security but the total value of the security provided shall not be lower than the required amount specified in Section 18.2 CDNT. If the bid security of any member of the consortium is determined to be invalid, the bid submission of that consortium will not be further considered or evaluated. If any member of the consortium violates the provisions of the law leading to non-refund of the bid security as stipulated in Section 18.5 CDNT, the bid security of all members of the consortium will not be refunded.

b) The members of the consortium agree on one member being responsible for providing the bid security for the consortium and other members within the consortium. In this case, the bid security may include the name of the consortium or the name of the member responsible for providing the bid security for the entire consortium, but the total value of the security provided shall not be lower than the required amount specified in Section 18.2 CDNT. If any member of the consortium violates the provisions of the law leading to non-refund of the bid security as stipulated in Section 18.5 CDNT, the bid security will not be refunded.”

c) Amend Section 40.1 in Section 40 Ensuring Contract Performance in Chapter I, Part 1 as follows:

“40.1. Before the contract takes effect, the successful bidder must provide a performance bond in the form of a bank guarantee issued by a bank or credit institution legally operating in Vietnam or in the form of a deposit, with contents and requirements as stipulated in Section 6.1 CDCT. In case the bidder uses a bank guarantee for contract performance, they must use Model No. 15 in Chapter VIII - Contract Forms or another model approved by the Project Owner.”

d) Amend Point e Section 1.2 in Section 1 Checking and Evaluating the Validity of Bid Submissions in Chapter III as follows:

“e) There is no violation of any of the cases stipulated in Section 18.3 CDNT regarding the bid security. For cases where bid security is provided in the form of a bank guarantee, the guarantee must be signed by a representative of a credit institution or a foreign bank branch established under Vietnamese law with the value and duration of validity, and the name of the Tender Inviter (beneficiary) as stipulated in Section 18.2 CDNT. For cases where bid security is provided in the form of a deposit, the Tender Inviter will manage the deposit made by the bidder in accordance with Sections 18.4 and 18.5 CDNT;”

đ) Amend the first bullet point in Section 6.1 of Chapter VII as follows:

"- Form of performance bond: ___ [based on the nature and requirements of the tender package, the Bidder provides a performance bond in the form of a bank guarantee issued by a bank or credit institution legally operating in Vietnam or in the form of a deposit. In case the Bidder submits a bank guarantee issued by a bank or credit institution legally operating in Vietnam, it must be an unconditional guarantee (payable upon demand, according to Model No. 15 in Chapter VIII - Contract Forms)].”

Article 2. Implementation clause

1. This Circular takes effect from April 27, 2023.

2. The following provisions cease to be effective from the date this Circular takes effect:

a) Clause 2 Article 3, Clause 4 Article 27, Point c Clause 3 Article 32, Point h Clause 4 Article 45 and Clause 9 Article 50 of Circular No. 15/2019/TT-BYT dated July 11, 2019 issued by the Minister of Health;

b) Article 5 of Circular No. 15/2020/TT-BYT dated August 10, 2020 issued by the Minister of Health promulgating the List of Drugs for Tendering, the List of Centralized Tendered Drugs, and the List of Drugs Subject to Price Negotiation;

c) Point a, Point b, Point c, Point đ Clause 8 Article 1 of Circular No. 29/2020/TT-BYT dated December 31, 2020 issued by the Minister of Health amending, supplementing, and abolishing certain legal normative documents issued by the Minister of Health, jointly issued.

Article 3. Transitional Provisions

For tender packages that have been approved for selection of contractors before the date this Circular takes effect, continue to implement according to the provisions of Circular No. 15/2019/TT-BYT dated July 11, 2019 issued by the Minister of Health and the provisions of Circular No. 15/2019/TT-BYT dated July 11, 2019 issued by the Minister of Health amended and supplemented by:

a) Circular No. 15/2020/TT-BYT dated August 10, 2020 issued by the Minister of Health promulgating the List of Drugs for Tendering, the List of Centralized Tendered Drugs, and the List of Drugs Subject to Price Negotiation;

b) Circular No. 29/2020/TT-BYT dated December 31, 2020 issued by the Minister of Health amending, supplementing, and abolishing certain legal normative documents issued by the Minister of Health, jointly issued;

c) Circular No. 15/2021/TT-BYT dated September 24, 2021 issued by the Minister of Health amending and supplementing certain articles of Circular No. 15/2019/TT-BYT dated July 11, 2019 issued by the Minister of Health.

Article 4. Reference Provisions

In case the referenced documents in this Circular are replaced or amended, they shall be applied according to the replaced or amended documents.

Article 5. Responsibilities for Implementation

The Director of the Department of Planning and Finance, the Director of the Drug Administration, the Director of the Traditional Medicine Management Department, the Director of the HIV/AIDS Prevention and Control Department, the Head of the Ministry's Office, the Inspector General of the Ministry, the Director of the National Centralized Procurement Center for Medicines, the Heads of units under and affiliated with the Ministry of Health, the Directors of Provincial Health Departments under centrally governed cities and provinces, pharmaceutical business establishments, and other relevant agencies, organizations, and individuals shall be responsible for implementing this Circular./.